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An Adapted Brazilian Cardioprotective Diet, Phytosterols and Krill Oil in Familial Hypercholesterolemia (DICA-FH)

NCT ID: NCT06331195

Last Updated: 2025-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-23

Study Completion Date

2026-12-31

Brief Summary

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The main objective of this randomized clinical trial is to evaluate the effects of the adapted Brazilian Cardioprotective Diet (DICA Br) supplemented or not with phytosterols and/or krill oil in patients with a probable or definitive diagnosis of familial hypercholesterolemia (FH) according to the the Dutch Lipid Clinic Network (Dutch MEDPED) criteria. In addition, the following will be considered secondary objectives: to perform participants´ whole genome sequencing (WGS); to evaluate the effects of the interventions on lipid profile biomarkers; to evaluate the frequency of mild, moderate and severe adverse events according to study groups; and to evaluate adherence rates according to study groups. In this study, 300 individuals will be randomly enrolled into four groups: 1) DICA Br adapted to the FH context (DICA-FH) + phytosterol placebo + krill oil placebo (control group); 2) DICA-FH + 2g/day of phytosterol + krill oil placebo; 3) DICA-FH + phytosterol placebo + 2g/day of krill oil; and 4) DICA-FH + 2g/day of phytosterol + 2g/day of krill oil. Primary outcomes will be LDL-cholesterol for groups phytosterol vs. placebo and lipoprotein(a) for groups krill oil vs. placebo after 120 days of follow up.

Detailed Description

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DICA-FH study is a superiority, factorial, and in parallel multicenter randomized placebo-controlled (double-dummy) clinical trial. The randomization will be in blocks stratified by research center, and the allocation ratio will be 1:1:1:1. Participants will come from at least 20 center sites in different Brazilian geographic regions.

Conditions

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Familial Hypercholesterolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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DICA-FH + placebo

Participants allocated into this arm (n= 75) will receive the DICA Br adapted to FH (DICA-FH) plus placebo of both phytosterol and krill oil during 120 days.

Group Type PLACEBO_COMPARATOR

Placebo phytosterol

Intervention Type OTHER

Placebo of phytosterol, in the same quantity of the active phytosterol.

Placebo krill oil

Intervention Type OTHER

Placebo of krill oil, in the same quantity of the active krill oil.

DICA-FH + phytosterol

Participants allocated into this arm (n= 75) will receive the DICA Br adapted to FH (DICA-FH) plus 2g/day of phytosterol and placebo of the krill oil during 120 days.

Group Type EXPERIMENTAL

Placebo krill oil

Intervention Type OTHER

Placebo of krill oil, in the same quantity of the active krill oil.

Phytosterol

Intervention Type DIETARY_SUPPLEMENT

2g/day will be provided to the participants, aiming to guarantee a minimum of 800mg/day of free phytosterols.

DICA-HF + krill oil

Participants allocated into this arm (n= 75) will receive the DICA Br adapted to FH (DICA-FH) plus 2g/day of krill oil and placebo of phytosterol during 120 days.

Group Type EXPERIMENTAL

Placebo phytosterol

Intervention Type OTHER

Placebo of phytosterol, in the same quantity of the active phytosterol.

Krill oil

Intervention Type DIETARY_SUPPLEMENT

2g/day will be provided to the participants, aiming to guarantee a minimum of 400mg/day of eicosapentaenoic (EPA) and docosahexaenoic (DHA) fatty acids.

DICA-HF + phytosterol + krill oil

Participants allocated into this arm (n= 75) will receive the DICA Br adapted to FH (DICA-FH) plus 2g/day of phytosterol and 2g/day of krill oil during 120 days.

Group Type EXPERIMENTAL

Phytosterol

Intervention Type DIETARY_SUPPLEMENT

2g/day will be provided to the participants, aiming to guarantee a minimum of 800mg/day of free phytosterols.

Krill oil

Intervention Type DIETARY_SUPPLEMENT

2g/day will be provided to the participants, aiming to guarantee a minimum of 400mg/day of eicosapentaenoic (EPA) and docosahexaenoic (DHA) fatty acids.

Interventions

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Placebo phytosterol

Placebo of phytosterol, in the same quantity of the active phytosterol.

Intervention Type OTHER

Placebo krill oil

Placebo of krill oil, in the same quantity of the active krill oil.

Intervention Type OTHER

Phytosterol

2g/day will be provided to the participants, aiming to guarantee a minimum of 800mg/day of free phytosterols.

Intervention Type DIETARY_SUPPLEMENT

Krill oil

2g/day will be provided to the participants, aiming to guarantee a minimum of 400mg/day of eicosapentaenoic (EPA) and docosahexaenoic (DHA) fatty acids.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Age ≥16 years;
* Definitive (certainty) or probable diagnosis of FH by the Dutch MEDPED criteria;
* Using one of the following treatment regimens for ≥6 weeks according to age:

\>= 20 years -\> simvastatin 40 mg; lovastatin 40 mg; pravastatin 80 mg; atorvastatin 20 mg; rosuvastatin 10 mg; pitavastatin 4 mg; fluvastatin 80 mg; atorvastatin 40- 80 mg; rosuvastatin 20 - 40 mg; atorvastatin 40 - 80 mg + ezetimibe 10mg; rosuvastatin 20 - 40 mg + ezetimibe 10mg; or simvastatin 40mg + ezetimibe 10mg.

16 to 19 years -\> simvastatin 10 - 40 mg; lovastatin 10 - 40 mg; pravastatin 10 - 40 mg; atorvastatin 10 - 40 mg; rosuvastatin 5 - 40 mg; cholestyramine 4 to 16 mg; ezetimibe 10mg (in combination with statin).

Exclusion Criteria

* Having a "possible" FH result according to the Dutch MEDPED criteria;
* TG ≥ 500mg/dL up to 6 months before screening for the study;
* Diagnosis of hypercholesterolemia due to a secondary cause recorded in the medical record;
* Food allergies (foods, dyes, preservatives);
* Contraindication to the use of phytosterols (for example: diagnosis of sitosterolemia);
* HIV positive on treatment with detectable viral load or AIDS;
* Chronic inflammatory or autoimmune diseases;
* Known liver disease, chronic kidney disease on dialysis or pancreatitis (acute and chronic);
* Cancer being treated or life expectancy \< 6 months;
* Episode of acute coronary syndrome in the last 60 days;
* Chemical dependency/alcoholism;
* Chronic use of anti-inflammatories, anticonvulsants and immunosuppressive drugs;
* Use of PCSK9 inhibitors (alirocumab, evolocumab, inclisiran);
* Pregnancy or lactation;
* Individuals who are unable to perform an anthropometric assessment, at the discretion of the investigator;
* Grade III/severe obesity (body mass index \[BMI\] ≥40kg/m² for adults or percentile \>99.9 or z-score \>+3 according to WHO/2006 growth curves for BMI/Age indicator for adolescents);
* Use of dietary supplements that may interfere with the outcomes of interest (dietary fiber modules, n-3 PUFA, essential fatty acids);
* Participation in other randomized clinical trials;
* Refusal to participate in the study, due to failure to sign the Free and Informed Consent Form.
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role collaborator

Hospital do Coracao

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Aline Marcadenti, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital do Coracao

Rachel Helena Machado, MSc

Role: STUDY_CHAIR

Hospital do Coracao

Erlon O Abreu-Silva, MSc

Role: STUDY_CHAIR

Hospital do Coracao

Locations

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Hcor

São Paulo, São Paulo, Brazil

Site Status RECRUITING

OCARA

Belém, , Brazil

Site Status RECRUITING

Centro Oncológico de Roraima

Boa Vista, , Brazil

Site Status RECRUITING

Instituto de Cardiologia e Transplantes do DF

Brasília, , Brazil

Site Status RECRUITING

Universidade do Mato Grosso do Sul

Campo Grande, , Brazil

Site Status RECRUITING

Universidade Federal do Mato Grosso

Cuiabá, , Brazil

Site Status RECRUITING

Hospital Oto Aldeota

Fortaleza, , Brazil

Site Status RECRUITING

Universidade Federal de Goiás

Goiânia, , Brazil

Site Status RECRUITING

Universidade Federal do Amapá

Macapá, , Brazil

Site Status RECRUITING

Centro de Pesquisas Clínicas Dr. Marco Mota

Maceió, , Brazil

Site Status RECRUITING

Universidade Federal do Amazonas

Manaus, , Brazil

Site Status RECRUITING

Universidade Estadual de Maringá

Maringá, , Brazil

Site Status RECRUITING

Santa Casa de Montes Claros

Montes Claros, , Brazil

Site Status RECRUITING

Centro de Estudos e Pesquisas em Moléstias Infecciosas

Natal, , Brazil

Site Status RECRUITING

Universidade Federal do Tocantins

Palmas, , Brazil

Site Status RECRUITING

Universidade Federal do Vale do São Francisco

Petrolina, , Brazil

Site Status RECRUITING

Instituto de Pesquisa e Ensino em Saúde

Porto Velho, , Brazil

Site Status RECRUITING

Centro de Pesquisa Silvestre Santé

Rio Branco, , Brazil

Site Status RECRUITING

Instituto Nacional de Cardiologia

Rio de Janeiro, , Brazil

Site Status RECRUITING

Hospital Ana Nery

Salvador, , Brazil

Site Status RECRUITING

InCor

São Paulo, , Brazil

Site Status RECRUITING

Instituto Dante Pazzanese de Cardiologia

São Paulo, , Brazil

Site Status RECRUITING

Universidade Federal de São Paulo

São Paulo, , Brazil

Site Status RECRUITING

Centro de Pesquisa Cardiolima

Teresina, , Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Aline Marcadenti, PhD

Role: CONTACT

Phone: +55 1130536611

Email: [email protected]

Rachel Helena Machado, MSc

Role: CONTACT

Phone: +55 1130536611

Email: [email protected]

Facility Contacts

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Aline Marcadenti, PhD

Role: primary

Jonathan S Sarraf

Role: primary

Juliana Gomes

Role: primary

Vitor Salvatore

Role: primary

Adriana Lugo

Role: primary

Tatiana Bering

Role: primary

Mateus Feitosa

Role: primary

Ana Paula Perillo

Role: primary

Álan Breno

Role: primary

Marco Mota

Role: primary

Luciane Alves

Role: primary

Sergio Seiji

Role: primary

Luciano Freitas

Role: primary

Natalia Lima

Role: primary

Sonia Lopes

Role: primary

Hildene Carneiro

Role: primary

Dhelio B Pereira

Role: primary

Odilson Silvestre

Role: primary

Elisa M Santos

Role: primary

Maurício A Barreto

Role: primary

Eduardo Lima

Role: primary

Cristiane Kovacs

Role: primary

Maria Cristina Izar

Role: primary

Carlos Eduardo Lima

Role: primary

Other Identifiers

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DICA-HF_MAIN

Identifier Type: -

Identifier Source: org_study_id